Proxomed tergumed 710 User manual

0123 tergumed®710
tergumed®710
User Manual

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In this user manual you will find information on the following products:
tergumed® 710 Extension
tergumed® 710 Flexion
tergumed® 710 Rotation
tergumed® 710 Lateral Flexion

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tergumed® 710 Cervical Trainer

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1Foreword
Dear Customer,
We would like to thank you for your confidence that you have chosen
products of proxomed Medizintechnik GmbH with your purchase and that
you share and support our vision of a healthy society. We are pleased that
our devices are in therapeutic use with you and support many patients in
their rehabilitation.
For more than 30 years, our customers worldwide have relied on our medical testing and training
systems. Our offerings as a full-service provider in active rehabilitation have grown continuously. In
addition to our core market in Germany, we are now represented in over 40 countries around the world
with our products and services for the benefit of a healthy society.
This success is based on a holistic understanding of the needs of our customers and their clients.
Maximum therapeutic success and personal quality of life improvement for all people are our incentive
in the changing healthcare system of the future.
For the health of your patients and the long-lasting use of our products, please read carefully this manual
with all important information for a safe and correct use of the devices.
You can also take advantage of our favorable maintenance and support contract offers, which ensure
that the value of the device technologies and software packages you use for your company is maintained
over the long term in accordance with the applicable Medical Device Operator Ordinance. If you have
any questions, please contact our service department.
Please keep the manual in a safe place and always have it available for further use.
Marcus Melching
CEO proxomed Medizintechnik GmbH

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Table of contents
1Foreword.................................................................................................................................... 4
2Legend........................................................................................................................................ 7
2.1 General symbolism........................................................................................................................................................7
2.2 Safety instructions.........................................................................................................................................................8
3Safety instructions .................................................................................................................... 9
3.1 Marking on the device.................................................................................................................................................9
3.2 Applied symbols for transport...............................................................................................................................10
3.3 Liability notice..............................................................................................................................................................11
3.4 Intended use.................................................................................................................................................................11
3.5 Indications and contraindications........................................................................................................................12
3.6 Patient target group..................................................................................................................................................12
3.7 Clinical benefit .............................................................................................................................................................12
3.8 Responsible operation..............................................................................................................................................12
3.9 Safety regulations.......................................................................................................................................................13
3.10 Combination with other products........................................................................................................................14
3.11 Side effects and residual risks................................................................................................................................14
3.12 Incident reporting.......................................................................................................................................................14
4Storage, transport and installation ....................................................................................... 15
5Commissioning........................................................................................................................ 17
6Training tips............................................................................................................................. 18
7Device descriptions ................................................................................................................. 20
7.1 tergumed® 710 Extension......................................................................................................................................20
Intended use.......................................................................................................................................................20
Settings.................................................................................................................................................................20
7.2 tergumed® 710 Flexion...........................................................................................................................................24
Intended use.......................................................................................................................................................24
Settings.................................................................................................................................................................24
7.3 tergumed ®710 Rotation........................................................................................................................................28
Intended use.......................................................................................................................................................28
Indications ...........................................................................................................................................................28

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Settings.................................................................................................................................................................29
7.4 tergumed® 710 Lateral Flexion............................................................................................................................32
Intended use.......................................................................................................................................................32
Indications ...........................................................................................................................................................32
Settings.................................................................................................................................................................32
7.5 tergumed® 710 Cervical Trainer..........................................................................................................................35
Intended use.......................................................................................................................................................35
Settings.................................................................................................................................................................35
7.6 General training settings .........................................................................................................................................39
8Maintenance, cleaning, servicing, disposal........................................................................... 40
9Accessories............................................................................................................................... 42
10 Technical data.......................................................................................................................... 44
11 Warranty .................................................................................................................................. 46

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2Legend
These operating instructions are part of the product and must be kept safe and
accessible throughout the entire service life. In the event of a change of ownership, the
operating instructions must be handed over to the new owner. If supplements to these
operating instructions are supplied, they must be added to the document.
2.1 General symbolism
Symbolism
Meaning
Setting range
•Indicates the range in which the respective setting can be
made.
The setting ranges are approximate values which may show
minimal deviations depending on the setting element.
Rotational adjustment range: Top view
If the adjustment is made in the
horizontal direction, the 90° of the
coordinate system always points in
the direction of the backrest of the
training device.
Rotational adjustment range: Front View
If the setting is made in the vertical
direction, the 90° of the coordinate
system always points upwards.
Linear adjustment range
If the adjustment is made in linear
direction, the zero point is at the
bottom of the training device.

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Setting levels
•Indicates the number of steps and the distances in the
respective setting range.
The setting ranges are approximate values which may show
minimal deviations depending on the setting element.
2.2 Safety instructions
The safety instructions presented in the operating instructions are categorized as follows:
Safety note
Meaning
WARNING
WARNING
•Indicates a potentially dangerous situation.
•If the situation is not avoided, death or serious injury may
result.
CAUTION
CAUTION
•Indicates a potentially dangerous situation.
•If the situation is not avoided, an injury may result.
ATTENTION
ATTENTION
•Indicates a potentially harmful situation.
•If the situation is not avoided, the device may be
damaged.

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3Safety instructions
3.1 Marking on the device
Figure
Description
Reference
Observe operating instructions
EN ISO 15223-1
Manufacturer, name, address, year of
manufacture
EN ISO 15223-1
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CE Mark
EU 2017/ 745
Serial number
EN ISO 15223-1
Unique Device Identification
EU 2017/ 745
Medical Device
Multi-year inspection sticker
Next test date
(marked by perforation)
EN 62353
Nameplate
Identification of the manufacturer, address, year
of manufacture, device designation, serial
number, UDI number as well as device-specific
information
EU 2017/ 745

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Follow instructions
Is additionally attached to devices with
electr. components
ISO 15223-1
3.2 Applied symbols for transport
Figure
Description
Reference
TOP - top here
-
DO NOT stack
-
Protect from moisture
-
Temperature range
ISO 15223-1
Humidity
ISO 15223-1

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3.3 Liability notice
The device has been built according to the current state of the art and recognized safety regulations.
Nevertheless, inadmissible misuse may result in hazards to persons and the device.
No design or development changes may be made to the device. The installation of additional
components or the removal of components is not permitted
The device may only be used if it is in perfect technical condition and in the intended use described.
3.4 Intended use
The devices are manufactured according to the international standards EN ISO 20957-1 and EN ISO
20957-2 as class S (studio); they are intended for commercial use e.g. in health-oriented fitness facilities
or physiotherapy practices for use on patients*.
Prior to the start of the first training session, the patient(s) will be briefed by qualified personnel.
Training with patients may only be performed under therapeutic supervision.
The device may only be used by adults (14 years and older); unsupervised children must be kept away
from the device.
The application is done in a sitting position.
The application is made only with intact skin.
If you feel unwell or have sudden symptoms, please stop training immediately and consult a doctor if
necessary.
To avoid injury, apply in tight-fitting clothing; tie up open, long hair if necessary.
Tergumed®devices are intended for indoor use only.
When using the devices with the smart assist option outside the German-speaking area, English
language skills are required for operation.
In case of deviations from the intended use, the manufacturer is not liable for damages.
CAUTION
Before starting their first workout, beginners and returners over the age of 45, as well
as people with existing illnesses and health problems, should consult a doctor.

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3.5 Indications and contraindications
The devices are indicated and may be used for the conditions listed below:
•Spinal syndromes with significant symptomatology
•Proven ligamentous prolapse (including postoperative) and significant protrusion outside the
acute stage
•Proven degenerative changes
•Proven spondylolyses and spondylolistheses
•Spinal injuries in the context of conservative and postoperative treatment
•In the case of recurrent intervertebral disc disease with significantly reduced ability to work
•Proven scoliosis and increased spinal curvature
The devices are contraindicated and must not be used for the conditions listed below:
•Febrile diseases
•Current pain at rest or during activity, as well as acute health complaints
•Existing pain in the musculoskeletal system, including after stretches, strains, torn muscle
fibers, sprains and disc protrusions
•Fresh fractures
•Osteoporosis in continued stages (grade 2 and 3)
•Hypertension in continued stages (grade 2 and 3 according to WHO)
•Artificial joint replacement at the knee and/or hip joint with unstable anchorage
•Severe neurological diseases with a tendency to muscle spasms
•Abdominal wall or inguinal hernia
•Pregnancy from the 2nd trimester
•Heart failure and coronary heart disease. Patients with high blood pressure may use the device
only after consultation with the treating physician
3.6 Patient target group
The devices are intended for professional use in health care facilities, such as orthopedic and
physiotherapy departments in hospitals, rehabilitation clinics, etc. Depending on the indication, patient's
health condition and treatment goal, the devices can be used in any phase of rehabilitation.
3.7 Clinical benefit
tergumed®710 devices support physiotherapeutic interventions. The clinical benefit for the patient lies
in the complementary use of the devices and the resulting improved muscle stabilization.
3.8 Responsible operation
These operating instructions are intended for the operator and the qualified personnel. All persons
working with the device must be trained in its use and must have read and understood the operating
instructions including the safety chapter.
Personnel must be informed before therapy begins and at regular intervals about the nature and scope
of activities and about possible hazards, such as any warnings.

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Instruction on the equipment (therapist, trainer, fitness trainer) and monitoring (therapist, sports
therapist, fitness trainer) may only be carried out by trained specialists. Authorization of the operator is
required.
Adjustments must not be operated under load. Before each adjustment, make sure that there is no load
from a lifted weight block. This may impair the permanent functionality of the components.
3.9 Safety regulations
The device may only be used in technically perfect condition in the intended use. In the event of defects
or malfunctions, please block the device and contact the manufacturer's service department.
It must be ensured, especially when changing the position of the unit without disassembly, that it stands
securely on level ground.
The protective cladding must not be removed. The device may only be operated with the protective
cladding mounted.
The warranty becomes void if modifications are made to the device or electronic devices for control and
measurement are attached that have not been carried out by specialist personnel authorized by the
manufacturer.
Defective parts of the device must be replaced immediately - in this case, it is advisable to stop using
the device until repairs have been made. Use only original accessories, otherwise no liability will be
accepted.
The device may only be opened by proxomed service or authorized personnel.
Do not reach with your hands between the moving bearings/rollers.

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3.10 Combination with other products
tergumed®710 devices are equipped with smart assist, in which intelligent control can be performed
using medical software. The smart assist was developed and tested in accordance with DIN EN 60601-1.
The currently valid version of the smart assist operating instructions (px tergu) must be consulted when
using the smart assist.
tergumed devices can be combined with medical technology products from the manufacturer Velamed/
Noraxon to perform EMG-based bio-feedback training with electromyographic measurements. The
combination of the products has been tested with regard to its effect and safe use.
3.11 Side effects and residual risks
The devices are developed in such a way that no critical side effects can occur. Occasional side effects,
such as muscle soreness and joint pain, may occur, usually after incorrect ergonomic adjustment or after
too intensive training. These symptoms should subside spontaneously after a few days.
3.12 Incident reporting
Please report any clinical events that occurred in and immediately after the use of the device directly to
the manufacturer at the address: vigilan[email protected].

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4Storage, transport and installation
The devices are usually delivered completely assembled. In rare cases, it may be necessary to ship the
units partially disassembled for transport reasons. In these cases, please contact the service
[email protected]
Surroundings
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Only in dry rooms free from seawater air (>65% humidity).
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Avoiding temperatures below 5 °C and above 45 °C.
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Avoid placing the units in heavily frequented rooms or near doors and
passageways.
Substrate
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The bearing capacity of the substrate must be according to the weight
of the device.
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Level and impact-resistant surface that can withstand the load of the
device and the maximum permissible body weight of the user of 200 kg.
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Small unevenness of the floor can be compensated for by means of the
adjustable feet that can be attached to the unit.
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Or a level surface must be created by using suitable shim material made
of shims or heavy-duty plastic.
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The levelling materials should not be susceptible to rust.
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When changing the position without disassembling the training device,
make sure that the device is standing securely on level ground.
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For PVC floors: the rubber sheets may cause reactions with the PVC floor,
in this case use appropriate cork sheets.
Setting up the
device
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Avoid hard, impact-like contact with the equipment.
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Compensation of unevenness via adjustable feet, which can be adjusted
in your height. Alignment with a spirit level.
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Protect the devices from shocks, scratches and moisture.

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Movement
dimension
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In general, make sure that the distance of at least 60 cm (starting from
the movement dimension) to other devices is maintained during
installation. However, the safety clearances may overlap.
Area until
next device
Area until
next device
Active
Training area

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5Commissioning
Before each start-up, check that the training device is in perfect technical condition.
Locking bolt on function, the locking button must engage automatically.
Protective cladding - present or damaged.
Screw connections - check for tight connection.
Welded joints - visual inspection.
Movement limitation, if available as an option.
Accessories available/functional.
Check for safe stand.
Make sure that aids, accessories, cables, etc. are not within the range of motion.
ATTENTION
Before initial start-up, the devices should stand at room temperature for at least 24
hours.
CAUTION
Before starting training, check the detent pins for tightness.
Do not pull on the locking bolts and pins during training.

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6Training tips
The device must be adjusted to the ergonomic conditions of the user before the first training. The
adjustment of the training device for the user is the responsibility of the qualified personnel.
•To prevent injuries and make training more effective, a general and special warm-up program
should be completed. Circulation and musculature are thus prepared for the loads.
•Select a safe and firm sitting position, with the pelvis and spine close to the seat. The back,
especially the lumbar spine, must be stabilized as best as possible during the exercise. If
available, the backrest is used to stabilize the spine.
•Correct positioning of the patient in the starting position contributes greatly to the quality,
effectiveness and safety of the exercise performance. The device axes and pivot points must be
matched as closely as possible to the axes of movement of the joints being exercised in order
to avoid the occurrence of compression and shear forces.
•Perform the movement slowly and in a controlled manner.
•The intensity of the load should be selected to be light at the beginning of the training. Increase
the load gradually to avoid overloading and discomfort.
•The equipment allows for double-leg or single-leg or double-arm or single-arm training.
•If mobility is restricted or pain occurs, immediately reduce the load and/or the extent of
movement.
•Training and therapy take place only in the pain-free area.
•During fast-impact exercises, the weight can be moved explosively. Controlled movement must
be ensured, especially in this training method, so that incorrect loads and injuries are avoided.
As a rule, concentric and eccentric ways of working the muscles are combined.
CAUTION
Improper or excessive training can lead to health problems
CAUTION
Pressurized breathing and the associated increase in intrathoracic pressure
can lead to damage to the vascular system in persons at risk. Perform
movement slowly and in a controlled manner.
WARNING
If you experience rapid heartbeat, dizziness, shortness of breath, nausea or
chest pain, profuse sweating or headache, please stop training immediately.

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•Different training methods are used. If training is done according to the repetition method,
several series of exercises are performed with appropriate breaks.
•The load intensity is based on the load capacity of the individual indications, the rehabilitation
phase and the treatment goal. For example, in order to adapt and accustom the injured structure
(connective tissue, cartilage, tendons, ligaments and joint capsule), the focus can be on weight-
bearing with low training intensity before the training of special strength skills, such as strength
endurance or maximum strength, begins with increasing intensity.
•In order to be able to reproduce the training positions made by a therapist/trainer during a later,
possibly independent training, all adjustment devices are provided with scales and numbered
alphabetically (A, B, C, ...).
•With all devices there is the possibility to stabilize the patient/clients optimally during the
training.
WARNING
Risk of injury. Keep a safety distance of at least 60 centimeters from moving parts.
CAUTION
Slowly lower the weight block during training to avoid straining the muscles.

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7Device descriptions
7.1 tergumed® 710 Extension
Intended use
tergumed®710 Extension is intended for muscular stabilization of the trunk erecting (back extensor)
muscles.
Settings
A - Seat height
49 cm - 61 cm
stepless
F - Start angle
E - Cushion
D - Knee pads
B - Backrest
A - Seat height
C - Footrest
Knee support
Weight tower